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Hematopoietic cell cryopreservation

BT302, BT322

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Clinical information

Clinical utility

The preservation of hematopoietic progenitor cells (HPCs) or mononuclear cells (MNCs) allows the patient to be prepared to receive the hematopoietic progenitor cell transplant (HPCT) after the cells have been obtained.

In the case of the manufacture of advanced therapy medicinal products (ATMP), cell preservation allows the results of quality controls to be available before the medicinal product is administered.

Preservation is performed at cryogenic temperatures, and must guarantee the functionality of the cells.

Method

Preservation is carried out in consecutive phases:

1. Introduction of the freezing solution (cryoprotective agent) into the cells.

2. Cooling protocol using devices with cooling temperature control.

3. Storage in liquid nitrogen or vapour phase containers.

4. Evaluation and freezing using control tubes.

Reference values

The estimated loss of nucleated cells after freezing is < 30%.

The expected viability of the cells after freezing is > 70%.

Specimen information

Product: Cryopreserved HPC.

Tube: 0.5 ml cryovials frozen and stored according to the same characteristics as the bag.

Volume: volume less than 200 ml.

Shelf life: 28 years.

Transport instructions: < -150 °C.

Storage instructions: < -150 °C.

Administrative information

BST code:  BT302 and BT322

Test description: when a HPC product requires cryopreservation for future use.

Synonyms: Cryopreserved HPC.

Section: Cell Therapy Service. Cell Therapy Laboratory.

Service: the fee includes the entire product divided into one or two bags (BT302) or into three or more bags (fee BT322) if there is a high number of cells or if cryopreservation in more than two bags is explicitly requested. The fee includes the performance of analytical quality controls.

References

Areman, E. M.; Loper, K., editors. Cellular therapy: Principles, methods, and regulations. 2nd ed. Bethesda (MD): AABB Press, 2016.

Quality

The BST has ISO 9001, ISO 14001, OSHAS 18001 and European Seal of Excellence 500+ quality certifications. The BST is accredited by CAT, JACIE-FACT, FACT-NETCORD and EFI. It complies with the guidelines of good manufacturing and good distribution practices.

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